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EC number: 948-032-2 | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
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- Flash point
- Auto flammability
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- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
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- Endpoint summary
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- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
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- Genetic toxicity
- Carcinogenicity
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- Specific investigations
- Exposure related observations in humans
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- Additional toxicological data
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 10. Jul. 2018 to 19. Jul. 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Terpene Dimers
- EC Number:
- 948-032-2
- IUPAC Name:
- Terpene Dimers
- Test material form:
- liquid
- Details on test material:
- Batch no. DF1710011
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- other: Salmonella typhimurium LT2, Strains: TA97a, TA98, TA100, TA102, TA1535
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-Mix
- Test concentrations with justification for top dose:
- The following nominal concentrations were prepared for the first experiment: 5 µL/plate, 1.5 µL/plate, 0.5 µL/plate, 0.15 µL/plate and 0.05 µL/plate
The following nominal concentrations were prepared for the second experiment: 5 µL/plate, 2.5 µL/plate, 1.25 µL/plate, 0.63 µL/plate, 0.31 µL/plate, 0.16 µL/plate and 0.08 µL/plate
Controls
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO, demineralised water, acetone
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- benzo(a)pyrene
- other: 2-Amino-anthracene (CAS-No.: 613-13-8), 4-Nitro-1,2-phenylene diamine (CAS-No.: 99-56-9)
- Details on test system and experimental conditions:
- Eight hours before the start of each experiment, one vial permanent culture of each strain was taken from the deep freezer and an aliquot was put into a culture flask containing nutrient broth. After incubation for eight hours at 37 ±1 °C, the cultures were used in the experiment. During the test, the cultures were stored at room temperature as to prevent changes in the titre. On the day of the test, the bacteria cultures were checked for growth visually. The incuba-tion chambers were heated to 37 ±1 °C. The water bath was turned to 43 ±1 °C. The table surface was disinfected. The S9 mix was freshly prepared and stored at 0 °C.
- Evaluation criteria:
- The colonies were counted visually and the numbers were recorded. A validated spread-sheet software (Microsoft Excel®) was used to calculate mean values and standard devia-tions of each treatment, solvent control and positive control.
The mean values and standard deviations of each threefold determination was calculated as well as the increase factor f(l) of revertant induction (mean revertants divided by mean spontaneous revertants) of the test item solutions and the positive controls. Additionally, the absolute number of revertants (Rev. Abs.) (mean revertants less mean spontaneous revertants) was given.
A substance is considered to have mutagenic potential, if a reproducible increase of re-vertant colonies per plate exceeding an increase factor of 2 in at least one strain can be observed. A concentration-related increase over the range tested is also taken as a sign of mutagenic activity.
Results and discussion
Test results
- Species / strain:
- other: Salmonella typhimurium LT2, Strains: TA97a, TA98, TA100, TA102, TA1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- The test item Terpene Dimers showed no increase in the number of revertants in all bac-teria strains in both experiments. Nearly all negative and all strain-specific positive control values were within the laboratory historical control data ranges indicating that the test conditions were adequate and that the metabolic activation system functioned properly. Based on the results of this study it is concluded that Terpene Dimers is not muta-genic in the Salmonella typhimurium test strains TA97a, TA98, TA100, TA102 and TA1535 in the absence and presence of metabolic activation under the experimental conditions in the present study.
Any other information on results incl. tables
Mean Revertants First Experiment
Strain |
TA97a |
TA98 |
TA100 |
TA102 |
TA1535 |
||||||
Induction |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
|
Demin. water |
Mean |
73 |
107 |
43 |
48 |
107 |
106 |
225 |
253 |
10 |
12 |
sd |
9.0 |
13.5 |
3.8 |
5.8 |
30.6 |
8.7 |
16.2 |
15.1 |
2.5 |
1.2 |
|
DMSO |
Mean |
88 |
123 |
40 |
44 |
87 |
91 |
215 |
221 |
15 |
11 |
sd |
17.4 |
16.7 |
2.6 |
5.8 |
11.6 |
14.7 |
24.4 |
12.2 |
2.6 |
1.2 |
|
Acetone |
Mean |
82 |
102 |
45 |
45 |
105 |
103 |
260 |
272 |
11 |
14 |
sd |
10.6 |
16.6 |
6.7 |
4.0 |
15.5 |
8.3 |
12.0 |
13.9 |
1.0 |
2.6 |
|
Positive |
Mean |
613 |
475 |
199 |
239 |
1195 |
1001 |
1312 |
1240 |
416 |
363 |
sd |
169.8 |
57.9 |
24.1 |
30.0 |
44.1 |
0.0 |
73.3 |
361.7 |
107.6 |
66.0 |
|
f(I) |
6.97 |
3.86 |
4.98 |
5.43 |
11.17 |
11.00 |
6.10 |
5.61 |
41.60 |
33.00 |
|
5 µL/plate |
Mean |
86 |
119 |
38 |
43 |
96 |
112 |
275 |
239 |
15 |
10 |
sd |
4.9 |
21.0 |
6.7 |
3.0 |
21.6 |
11.9 |
15.5 |
14.2 |
4.2 |
0.6 |
|
f(I) |
1.05 |
1.17 |
0.84 |
0.96 |
0.91 |
1.09 |
1.06 |
0.88 |
1.36 |
0.71 |
|
1.5 µL/plate |
Mean |
80 |
94 |
36 |
39 |
101 |
98 |
238 |
237 |
10 |
12 |
sd |
14.0 |
8.0 |
7.6 |
3.5 |
5.0 |
3.5 |
17.8 |
33.6 |
0.0 |
3.8 |
|
f(I) |
0.98 |
0.92 |
0.80 |
0.87 |
0.96 |
0.95 |
0.92 |
0.87 |
0.91 |
0.86 |
|
0.5 µL/plate |
Mean |
83 |
97 |
44 |
41 |
112 |
93 |
275 |
206 |
13 |
14 |
sd |
6.4 |
2.3 |
6.0 |
3.5 |
4.0 |
7.6 |
38.0 |
6.9 |
4.6 |
1.5 |
|
f(I) |
1.01 |
0.95 |
0.98 |
0.91 |
1.07 |
0.90 |
1.06 |
0.76 |
1.18 |
1.00 |
|
0.15 µL/plate |
Mean |
90 |
96 |
45 |
44 |
110 |
105 |
239 |
235 |
13 |
13 |
sd |
5.5 |
14.4 |
5.7 |
4.4 |
15.1 |
20.2 |
26.6 |
19.4 |
1.2 |
2.9 |
|
f(I) |
1.10 |
0.94 |
1.00 |
0.98 |
1.05 |
1.02 |
0.92 |
0.86 |
1.18 |
0.93 |
|
0.05 µL/plate |
Mean |
80 |
96 |
42 |
43 |
91 |
115 |
242 |
203 |
14 |
10 |
sd |
7.8 |
11.6 |
2.5 |
6.1 |
2.6 |
23.9 |
36.7 |
23.2 |
3.5 |
1.5 |
|
f(I) |
0.98 |
0.94 |
0.93 |
0.96 |
0.87 |
1.12 |
0.93 |
0.75 |
1.27 |
0.71 |
Mean Revertants Second Experiment
Strain |
TA97a |
TA98 |
TA100 |
TA102 |
TA1535 |
||||||
Induction |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
|
Demin. water |
Mean |
81 |
106 |
43 |
42 |
93 |
100 |
341 |
397 |
10 |
12 |
sd |
11.1 |
9.5 |
6.9 |
7.2 |
9.5 |
7.2 |
32.3 |
16.7 |
2.0 |
1.7 |
|
DMSO |
Mean |
102 |
113 |
42 |
39 |
92 |
95 |
408 |
389 |
11 |
10 |
sd |
4.4 |
6.9 |
8.2 |
4.0 |
5.3 |
8.1 |
13.9 |
25.7 |
1.2 |
2.0 |
|
Acetone |
Mean |
80 |
120 |
40 |
40 |
87 |
86 |
411 |
397 |
10 |
9 |
sd |
5.9 |
9.3 |
2.1 |
7.9 |
6.0 |
8.7 |
24.4 |
116.6 |
1.5 |
1.5 |
|
Positive |
Mean |
570 |
735 |
549 |
445 |
1091 |
1001 |
1176 |
1235 |
199 |
122 |
sd |
137.4 |
135.4 |
32.3 |
28.1 |
37.8 |
0.0 |
28.8 |
20.1 |
64.0 |
19.1 |
|
f(I) |
5.59 |
6.50 |
13.07 |
11.41 |
11.73 |
10.54 |
2.88 |
3.17 |
19.90 |
12.20 |
|
5 µL/plate |
Mean |
69 |
77 |
41 |
37 |
90 |
96 |
445 |
345 |
11 |
10 |
sd |
13.0 |
2.1 |
6.1 |
3.5 |
6.0 |
3.8 |
60.0 |
20.1 |
1.5 |
0.6 |
|
f(I) |
0.86 |
0.64 |
1.03 |
0.93 |
1.03 |
1.12 |
1.08 |
0.87 |
1.10 |
1.11 |
|
2.5 µL/plate |
Mean |
74 |
85 |
43 |
38 |
100 |
105 |
428 |
401 |
11 |
11 |
sd |
5.8 |
3.8 |
13.9 |
4.0 |
15.0 |
18.5 |
26.2 |
52.2 |
2.3 |
2.5 |
|
f(I) |
0.93 |
0.71 |
1.08 |
0.95 |
1.15 |
1.22 |
1.04 |
1.01 |
1.10 |
1.22 |
|
1.25 µL/plate |
Mean |
72 |
87 |
47 |
42 |
93 |
98 |
445 |
419 |
13 |
10 |
sd |
10.0 |
4.6 |
15.5 |
4.6 |
1.2 |
19.6 |
40.1 |
11.5 |
2.9 |
3.5 |
|
f(I) |
0.90 |
0.73 |
1.18 |
1.05 |
1.07 |
1.14 |
1.08 |
1.06 |
1.30 |
1.11 |
|
0.63 µL/plate |
Mean |
64 |
73 |
43 |
43 |
97 |
83 |
371 |
411 |
13 |
11 |
sd |
7.2 |
12.2 |
6.0 |
7.0 |
11.3 |
4.2 |
50.3 |
16.2 |
2.1 |
2.1 |
|
f(I) |
0.80 |
0.61 |
1.08 |
1.08 |
1.11 |
0.97 |
0.90 |
1.04 |
1.30 |
1.22 |
|
0.31 µL/plate |
Mean |
92 |
79 |
35 |
38 |
87 |
95 |
440 |
421 |
11 |
10 |
sd |
9.9 |
19.7 |
3.8 |
7.5 |
5.6 |
13.3 |
58.9 |
30.0 |
3.5 |
2.1 |
|
f(I) |
1.15 |
0.66 |
0.88 |
0.95 |
1.00 |
1.10 |
1.07 |
1.06 |
1.10 |
1.11 |
|
0.16 µL/plate |
Mean |
87 |
99 |
38 |
42 |
91 |
95 |
413 |
429 |
10 |
11 |
sd |
10.4 |
13.8 |
1.0 |
9.0 |
12.9 |
23.2 |
8.3 |
47.7 |
1.5 |
5.6 |
|
f(I) |
1.09 |
0.83 |
0.95 |
1.05 |
1.05 |
1.10 |
1.00 |
1.08 |
1.00 |
1.22 |
|
0.08 µL/plate |
Mean |
78 |
90 |
44 |
41 |
93 |
98 |
423 |
241 |
10 |
12 |
sd |
6.4 |
3.6 |
3.1 |
4.2 |
14.5 |
3.5 |
14.0 |
30.3 |
1.0 |
4.5 |
|
f(I) |
0.98 |
0.75 |
1.10 |
1.03 |
1.07 |
1.14 |
1.03 |
0.61 |
1.00 |
1.33 |
Applicant's summary and conclusion
- Conclusions:
- In all experiments, no precipitation of the test item Terpene Dimers was observed at any of the tested concentrations up to 5 µL/plate. In the first and the second experiment, the test item caused no cytotoxicity towards all bacteria strains. The confirmation tests of the genotype did not show any irregularities. The control of the titre was above the demanded value of 109 bacteria/mL. Nearly all of the means of all replicates of the spontaneous revertants (in negative and solvent controls) were within the range of the historical data of the test facility. All numbers of revertant colonies of the positive controls were within the range of the historical data of the laboratory and were increased in comparison with the negative controls, which demonstrated the mutagenic potential of the diagnostic mutagens. Since all criteria for acceptability have been met, the study is considered valid.
- Executive summary:
Two valid experiments were performed.
The study procedures described in this report were based on the most recent OECD and EC guidelines. The test item Terpene Dimers was tested in the Salmonella typhimurium reverse mutation assay with five strains of Salmonella typhimurium (TA97a, TA98, TA100, TA102 and TA1535).
The test was performed in two experiments in the presence and absence of metabolic activation, with +S9 standing for presence of metabolic activation, and –S9 standing for absence of metabolic activation.
Experiment 1:
In the first experiment,the test item (dissolved in acetone) was tested up to concentrations of 5 µL/plate in the absence and presence of S9-mix in the strains TA97a, TA98, TA100, TA102 and TA1535 using the plate incorporation method. The test item showed no precipitates on the plates at any of the concentrations. The bacterial background lawn was not reduced at any of the concentrations and no relevant decrease in the number of revertants was observed in all bacteria strains. The test itemshowed no signs of toxicity towards the bacteria strains in both the absence and presence of metabolic activation. The results of this experiment showed that none of the tested concentrations showed a significant increase in the number of revertants in all tested strains, in the presence and the absence of metabolic activation.
Experiment 2:
Based on the results of the first experiment,the test item was tested up to concentrations of 5 µL/plate in the absence and presence of S9-mix in all bacteria strains using the pre-incubation method.
The test item showed no precipitates on the plates at any of the concentrations. The bacterial background lawn was not reduced at any of the concentrations and no relevant decrease in the number of revertants was observed in all bacteria strains. The test itemshowed no signs of toxicity towards the bacteria strains in both the absence and presence of metabolic activation. The results of this experiments showed that the test item caused no increase in the number of revertants in all bacteria strains compared to the solvent control, in both the absence and presence of metabolic activation. The test item did not induce a dose-related increase in the number of revertants colonies in all strains, in the presence and absence of metabolic activation.
Based on the results of this study it is concluded that Terpene Dimers is not mutagenic in the Salmonella typhimurium strains TA97a, TA98, TA100, TA102 and TA1535 in the absence and presence of metabolic activation under the experimental conditions in this study.
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